Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib

Key facts

Study ID

NCT00418626

Run by

Novartis Pharmaceuticals

People needed

27

Starts

2006-11-01

Last updated by the study team

2012-03-08

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult male (18 -70 yrs)
• Body weight must be ≥ 50 kg and < 120 kg, with a body mass index (BMI) >18 but < 35.
• Laboratory parameters values within the normal range

You may not qualify if…

• Contraindication or hypersensitivity to receiving nilotinib
• Smokers or those who use of tobacco products or products containing nicotine
• A past medical history of clinically significant Electrocardiogram abnormalities or a history/family history of long QT-interval syndrome.
• History of fainting spells.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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